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FDA flip flops & approves potent sunblock

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PostedJul 26, 2006 at 7:42 pm

Why Is the Best Sunscreen Blocked by FDA?
America Denied Sun Shield That Other Countries Enjoy

By John Stossel, ABC News

June 17, 2005 – We think of July and August as the peak of summer, but when
it comes to sunburn, now is the peak. Next Tuesday, June 21st, is the
longest day of the year, when the sun is highest in the sky, so it’s now
that the sun does the most damage.
Like most people, you probably think you know what to do about it. You
slather on the sunscreen when you’re out in the sun.

Our suntan lotions are good at screening out the sun’s UVB rays – the ones
that cause sunburn and skin cancers – but most people don’t realize their
sunscreens don’t offer much protection against UVA rays, the ones that put
wrinkles in your skin.

“Ultraviolet A light ages your skin. And the reason it does that, it’s a
longer wavelength, so it can penetrate deeper into the skin, and instead of
attacking the upper layers of the skin where skin cancer often forms, it
attacks the layers that give your skin its tone, its elasticity, as we call
it. . You get the lines, the wrinkles, all the things associated from
aging,” said Dr. Darrell Rigel, clinical professor of dermatology at New
York University.

But there’s good news. Lotions that contain the ingredients Oxybenzone,
Titanium Dioxide or Parsol 1789 block out some UVA rays.

Doctors say a chemical called Mexoryl offers even better protection.

“It produces a product which gives us almost perfect protection against
sunshine,” said Dr. Vincent DeLeo, chairman of dermatology at Columbia
University.

People are happily protecting themselves with Mexoryl on the beaches of Rio
de Janeiro, the streets of Paris, in Canada, Mexico and Australia.

Mexoryl “is the No. 1 individual ingredient in terms of protection from
Ultraviolet A radiation,” Rigel said.

But even though dermatologists say Mexoryl is the best, you cannot legally
buy it in the United States. It’s illegal, because the Food and Drug
Administration won’t approve it. They won’t even say why. The FDA is charged
with making sure no drug is sold unless the government is convinced it’s
safe and effective. Dermatologists think it’s just stuck in the bureaucracy.
It routinely takes 12 to 15 years for a drug to get approval. After an
approved drug – Vioxx, for example – gets bad publicity as a health risk,
the FDA gets particularly cautious.

But is there no common sense here? All drugs have risks as well as benefits.
Mexoryl has been in use in other countries for 13 years. It’s passed many
safety tests. Why won’t our FDA even talk about it?

Although buying or selling sunscreens with Mexoryl is illegal in the United
States, that doesn’t mean sunscreens with Mexoryl aren’t bought and sold
here. We found it at some pharmacies. It was expensive – $30 to $50.

“People really want this stuff. People go to pharmacies and they keep it
under the counter, like it’s a secret ingredient, like prohibition or
something and people will still buy it,” Rigel said.

I don’t fault the pharmacies, they’re serving their customers.

Everyone is always telling us, protect yourself from the sun, but then the
government won’t give us permission to have the best sunscreen?

Give me a break.

=============================
Slather It On: Potent New Sunscreen Approved by FDA

Long Available in Europe, New Compound Also Protects Against UVA Rays

By JOY VICTORY, ABCNews.com Health Producer
July 24, 2006 – For the first time since 1988, the Food and Drug
Administration today approved a new type of sunscreen compound that protects
skin from shortwave ultraviolet A light and doesn’t break down as easily as
other products.
Most sunscreens available in the United States protect only against
long-wave UVA and both forms of ultraviolet B light. But the new compound,
known as ecamsule, has long been available in Europe and Canada. It is made
by the L’Oreal cosmetics company.

The new product is considered a superior sunscreen chemical because of its
ability to block UVA light – a harmful, wrinkle-causing form of sunlight –
and because it lasts longer in the sun.

The product, Mexoryl SX, contains two standard sunscreen chemicals as well
as ecamsule and will be sold as a daily moisturizer cream. It should be on
pharmacy shelves sometime this fall, but it’s not known how much it will
cost. It will be sold under the name Anthelios SX.

Many dermatologists are happy about the news.

“We are delighted that an effective sunscreen agent has been approved by the
. . . FDA. We’re aware that this ingredient has been available in Europe
since 1993 and we know that it is an effective UVA sunblocking agent,” said
Dr. Stephen Stone, president of the Academy of Dermatology. “. . . It is an
effective UVA blocker. It will have some role in protection from skin cancer
and photo-aging – our term for aging from sun exposure, like wrinkles and
skin pigmentation.”

This is primarily due to the product’s better UVA blocking abilities.

“UVA accounts for over 80 percent of the damage that occurs to the skin in
terms of aging, DNA damage and, ultimately, skin cancer,” said Dr. Darrell
Rigel, clinical professor of dermatology at New York University Medical
Center, in a press release issued by L’Oreal. “UVA rays are present all year
long, even in the winter, and they can penetrate through clouds and
windows.”

In an interview last year with ABC’s “20/20,” Dr. Vincent DeLeo, chairman of
the dermatology department at Columbia University, said the European
equivalent was sorely needed in the United States.

“It produces a product which gives us almost perfect protection against
sunshine,” he said.

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